JP6820864B2 - 操向可能な医療器具、システムおよび使用方法 - Google Patents
操向可能な医療器具、システムおよび使用方法 Download PDFInfo
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Classifications
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- A61M25/00—Catheters; Hollow probes
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- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
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Description
[0001]本出願は、参照によって本明細書に組み込まれる2015年4月24日出願の米国特許仮出願第62/152,741号の優先権を主張するものである。
参照による組み込み
[0002]本明細書で言及するすべての公刊物および特許出願は、各々の公刊物または特許出願が参照によって組み込まれるものとして具体的かつ個別に示されているのと変わらずに参照によって本明細書に組み込まれる。
トローラと;を備える操向可能な医療器具である。
[0010]幾つかの実施形態では、外側背骨部は、外側管状部材の周りに180度未満の範囲で延びる第1の材料の直線状セグメントを備える。第1の材料は、外側管状部材の周りに180度超の範囲で延びる材料の第2のセグメントよりも高いデュロメータ値を有することができる。
[0012]幾つかの実施形態では、線状補強部材の遠位端は、操向可能部位の遠位端よりもさらに遠位にある。線状補強部材の遠位端は、実質的に外側管状部材の遠位端まで延びることができる。
[0014]本開示の一態様は、アクチュエータおよび駆動部材を含む外部コントローラと;操向可能部位の遠位の箇所で互いに軸方向に固定されている第1および第2の管状部材を含む細長い操向可能な器具と;を備え、第1および第2の管状部材の一方が他方の中にあり、第1の管状部材の近位端が、駆動部材の軸方向移動が第1の管状部材の近位端の軸方向移動を引き起こすように駆動部材に操作可能に固定され、アクチュエータが、アクチュエータを第1の方向に操作したときに駆動部材が近位に移動し、第1の管状部材が引っ張られ、第2の管状部材が圧縮されて、操向可能部位が第1の方向に操向されるように、また、アクチュエータを第1の方向とは反対の第2の方向に操作したときに駆動部材が遠位に移動し、第1の管状部材が圧縮され、第2の管状部材が引っ張られて、操向可能部位が第1の方向とは異なる第2の方向に操向されるように駆動部材と操作可能に接続される、操向可能な医療装置である。
[0016]幾つかの実施形態では、アクチュエータはナットと連結され、ナットは駆動部材に接続する。
[0085]その内部で浮動ライナが浮動する外部構造は適当などのような管状部材であってもよい。例えば、外部構造はカテーテル、案内器具、操向可能な器具などであることができる。幾つかの実施形態では、外部構造は中立的な湾曲の選択性を有しており、操向するようには意図されていない。この実施形態では、外部構造によって軸方向および径方向の剛性が与えられ、それによってよじれが起こりにくくされる一方、浮動ライナも潤滑をもたらしつつ、外部構造によってよじれの発生を抑え込まれる。
[0126]図23は例示的な管状部材410の一部位を平面展開図で示している。管状部材410は、背骨部412および414を画定する断続的ならせん形スロット418を備える。管状部材410は、器具の周りに互いに180度をなす2つの背骨部を有する。らせん形の切欠きパターンはそれ自体180度ごとに反復して、実質的に直線的な背骨部を画定する。管状部材410もまた、ねじり剛性を与える複数のインターロック機構420を備える。最大の伸張/圧縮は軸416で得られる。
[0172]この実施形態では、内側シャフトの湾曲面は図47Bではページ面である。この実施形態(および本明細書のそれ以外のもの)における湾曲面は背骨部、長手方向軸および選択的湾曲軸を含む平面である。背骨部は図47Bのシャフトの頂部を通って延びる(ただし、幾つかの実施形態では背骨部自体は必ずしも直線的な「軸」である必要はない。例えば、背骨部は、「軸」であるシャフトの長手方向軸と平行をなす正中線を有することができる)。選択的湾曲軸はページ面内にあり、図47Bのシャフトの底部を通って延びる。圧縮力がかかると、シャフトは湾曲面内をページ下方に湾曲する。湾曲したとき、背骨部、長手方向軸および選択的湾曲軸は湾曲面内にとどまる。セクション473とセクション472の間の継ぎ目に関しては、セクション473の最遠位位置は湾曲面内の背骨部にある。セクション472の最近位位置は選択的湾曲軸沿いにある。したがって、デュロメータ値が高めの材料の最遠位位置は背骨部沿いにあり、デュロメータ値が比較的低めの材料の最近位位置は選択的湾曲軸沿いにある。上述の通り、長手方向軸に対して垂直な横断面のシャフトの平均デュロメータ値はセクション472の最近位位置からセクション473の最遠位位置まで連続的に変化する。
[0174]内側部材は操向可能部位の近位にある近位部474を含む。近位部474は操向可能部位よりも全体に剛性が高い。幾つかの実施形態では、近位部474は、ナイロンまたはベスタミドのようなポリアミドである。図47Eは近位部474の(図47Aの)F−F横断面を示している。
[0177]図47Fは図47Aの器具の遠位端のJ−J断面を示している。コイル475の両端は、ベスタミドなどの薄いポリアミドに埋め込まれており、両端の遠位に対しては図47Eでは478の符号が与えられている。補強部材477も見ることができ、その遠位端は器具の遠位端の近位にある。内側ライナ476は器具の遠位端まで余すところなく延びる。
[0197]幾つかの実施形態では、操向可能部位の長さSは3cmから9cmの間で、3cmから8cmの間などであり、または4cmから7cmの間で、4.5cm、4.6cm、4.7cm、4.8cm、4.9cm、5.0cm、5.1cm、5.2cm、5.3cm、5.4cm、5.5cm、5.6cm、5.7cm、5.8cm、5.9cm、6.0cm、6.1cm、6.2cm、6.3cmまたは6.4cmなど(これらだけに限らない)である。
[0203]第1および第2のセグメント551および552は同じ構成を持つが、互いに180度オフセットして対向する。しかし、第1および第2のセグメントは必ずしも同じ構成である必要はない。
[0212]図52Aは、内側管状部材550、外側管状部材580(図48A〜48Dに示した外側管状部材と同一または類似のものであってよい)、および遠位柔軟セクション582を含む例示的な操向可能な医療器具の一部位を示したものである。図52Bおよび52Cはそれぞれ図52Aに示したA−A断面およびB−B断面を表したものである。図52Cは、内側管状部材550、外側管状部材580、および内側管状部材の補強部材557であって、外側管状部材580にある高めのデュロメータ値のセグメント581の中間点に対して180度反対側にある補強部材557を表している。この設計では、また本明細書で繰り返し説明しているように、内側および外側管状部材の背骨部は180度オフセットされている。比較的低いデュロメータ値の材料のセグメント583は外側管状部材の周りに180度超にわたって延びる。
[0215]図53Aは、ハンドルの形をした例示的な外部コントローラであって、本明細書に記載する操向可能な器具を送り込んで、操作するように適合された外部コントローラを示している。外部コントローラ5300は、本明細書には特に記載されていない他の操向可能な器具を制御するように適合されており、または適合されることができる。一実施形態では、外部コントローラ5300は、上述したもののような操向可能管状部材を含んだ例示的な操向可能なシースシステム1000の操向を制御する。操向可能なシースシステム1000はハンドル部位1200によって操作することができる。
[0226]図54Cは、外側管状部材620の遠位領域である、図54Aに示した詳細Fを示している。操向可能部位622の遠位には、操向可能部位622より短くてよいセクション627があり、セクション627の遠位には遠位先端部628がある。図54Cはまた、外側管状部材620が任意選択の補強部材631(この実施形態ではKevlarストリップ)と第2の補強部材632(この実施形態では編み材)とをさらに含むことを示している。補強ストリップは、断面寸法が一様であるかまたは一様でない断面幾何形状を有することができる。例えば、断面幾何形状は、断面寸法が均一直径であるように、円形であってもよい。あるいは、断面幾何形状は、断面寸法が高さよりも大きい幅またはその逆を含むように、長方形または楕円形であってもよい。それによって、断面幾何形状は、1つの方向、例えばストリップの水平軸の方向において、別の方向、例えばストリップの垂直軸の方向におけるよりも強い補強をもたらすことができる。補強部材631は外側管状部材620の背骨部に内設され、特に第1のセグメント623に内設される。補強部材631は軸方向に(外側管状部材620の長手方向軸に対して平行に)延びて第1のセグメント623の中間点を通る。別の言い方をすれば、補強部材631と外側管状部材620の中心軸とを含む平面は、第1のセグメント623を2つの仮想の対称なセクションに分割することができる。幾つかの実施形態では、補強部材631はKevlar線である。
Claims (9)
- 操向可能部位の長さに沿って延びる第2のセグメント材料よりも高いデュロメータ値を有し、操向可能部位の長さに沿って延びる、第1の材料の内側背骨部を有する内側柔軟管状部材と、
操向可能部位の遠位の固定箇所で前記内側柔軟管状部材に軸方向に固定されている外側柔軟管状部材であって、前記外側柔軟管状部材の周りに180度超の範囲で延びる第2のセグメント材料よりも高いデュロメータ値を有する、前記外側柔軟管状部材の周りに180度未満の範囲で延びる第1の材料の直線状セグメントを有し、前記内側背骨部からずらされている外側背骨部を有する外側柔軟管状部材と、
前記内側背骨部の高いデュロメータ値の前記第1の材料又は前記外側背骨部の高いデュロメータ値の前記第1の材料の少なくとも一方の内で延びる線状補強部材と、
前記内側および外側柔軟管状部材の一方を引っ張り他方を圧縮して前記操向可能部位を操向するように前記内側および外側柔軟管状部材と操作可能に接続する外部コントローラと
を備える操向可能な医療器具。 - 前記線状補強部材は、前記内側背骨部と前記外側背骨部の両方の内部でそれぞれ延びる、請求項1に記載の操向可能な医療器具。
- 前記外側背骨部の前記線状補強部材および前記内側背骨部の前記線状補強部材が、前記操向可能な医療器具の周りで180度離れる、請求項2に記載の操向可能な医療器具。
- 線状補強部材が、前記操向可能な医療器具の周りで前記内側背骨部から180度離れる、請求項1に記載の操向可能な医療器具。
- 前記外側柔軟管状部材が、前記操向可能部位に編み構造の補強部材をさらに備える、請求項1に記載の操向可能な医療器具。
- 前記線状補強部材が、前記編み構造の補強部材の中に織り込まれる、請求項5に記載の操向可能な医療器具。
- 前記線状補強部材の遠位端が、前記操向可能部位の遠位端よりもさらに遠位にある、請求項1に記載の操向可能な医療器具。
- 前記線状補強部材の遠位端が、実質的に前記外側柔軟管状部材の遠位端まで延びる、請求項7に記載の操向可能な医療器具。
- 前記線状補強部材の遠位端が、前記内側柔軟管状部材および外側柔軟管状部材が共に軸方向に固定される箇所まで延びる、請求項1に記載の操向可能な医療器具。
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2016
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- 2016-04-25 CN CN201680037090.9A patent/CN107708785B/zh active Active
- 2016-04-25 EP EP16784087.5A patent/EP3285849A4/en active Pending
- 2016-04-25 AU AU2016253129A patent/AU2016253129A1/en not_active Abandoned
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- 2016-04-25 WO PCT/US2016/029207 patent/WO2016172706A1/en active Application Filing
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US11052226B2 (en) | 2021-07-06 |
JP2018517450A (ja) | 2018-07-05 |
EP3285849A1 (en) | 2018-02-28 |
CA2982823A1 (en) | 2016-10-27 |
US20170080186A1 (en) | 2017-03-23 |
HK1244723A1 (zh) | 2018-08-17 |
CN107708785B (zh) | 2021-08-20 |
CN107708785A (zh) | 2018-02-16 |
WO2016172706A1 (en) | 2016-10-27 |
EP3285849A4 (en) | 2018-12-26 |
AU2016253129A1 (en) | 2017-10-26 |
US20170203077A1 (en) | 2017-07-20 |
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